FDA Product Code QPX: Negative Pressure Wound Therapy, Non-powered Suction Pump, Chemical
For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.
Leading manufacturers include Aatru Medical, LLC.
FDA 510(k) Cleared Negative Pressure Wound Therapy, Non-powered Suction Pump, Chemical Devices (Product Code QPX)
About Product Code QPX - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QPX since 2021, with 1 receiving FDA clearance (average review time: 452 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
QPX devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →